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- || Orencia (abatacept) / BMS, Actemra IV (tocilizumab) / Roche, JW Pharma
Review, Journal: Sjögren's syndrome: Old and new therapeutic targets. (Pubmed Central) - Aug 7, 2021
Abatacept and belimumab, already licensed for the treatment of RA and lupus respectively, as well combination regimens of both rituximab and belimumab hold some promise in alleviation of SS-specific complaints, but data from large controlled trials are awaited...While targeting of cathepsin-S (Petesicatib), inducible costimulator of T cells ligand (prezalumab), and lymphotoxin beta receptor (baminercept) failed to fulfil the primary outcome measures, preliminary results from two randomized placebo controlled trials on CD40 blockade (Iscalimab) and B-cell activating factor receptor (Ianalumab) inhibition resulted in significant reduction of SS disease activity, with a favorable so far safety profile. Results from administration of other kinase inhibitors, a transmembrane activator and calcium-modulator and cytophilin ligand interactor TACI fusion protein (RC18), as well as low dose recombinant interleukin-2 to expand T-regulatory cells are currently awaited.
- || hydroxychloroquine / Generic mfg., cyclosporine / Generic mfg.
Clinical, Journal: An Update on the Management of Childhood-Onset Systemic Lupus Erythematosus. (Pubmed Central) - Jul 22, 2021
Anti-interferon therapies (sifalimumab and anifrolumab) have shown beneficial results in phase II randomized control trials in adult SLE patients, as have some Janus kinase inhibitors, and these could be alternative treatments for pediatric patients with severe interferon-mediated inflammatory disease in the future. In addition, strict control of proteinuria and blood pressure is required in cSLE, especially with angiotensin-converting enzyme inhibitor and angiotensin receptor blocker use.
- ||| Tai'ai (telitacicept) / Rongchang Pharma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: A Study of RC18 Administered Subcutaneously to Subjects With Primary IgA(Immunoglobulin A) Nephropathy (clinicaltrials.gov) - Jul 19, 2021
P2, N=44, Completed, Sponsor: RemeGen Co., Ltd.
In addition, strict control of proteinuria and blood pressure is required in cSLE, especially with angiotensin-converting enzyme inhibitor and angiotensin receptor blocker use. Active, not recruiting --> Completed | N=30 --> 44 | Trial completion date: Dec 2021 --> May 2021 | Trial primary completion date: Oct 2021 --> May 2021
- |||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
New P2 trial, Monotherapy: RC48-C018: A Study of RC48-ADC for the Treatment of HER2-expressing Gynecological Malignancies (clinicaltrials.gov) - Jul 15, 2021
P2, N=120, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- ||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Metastases: A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases (clinicaltrials.gov) - Jul 9, 2021
P3, N=301, Recruiting, Sponsor: RemeGen Co., Ltd.
Active, not recruiting --> Completed | N=30 --> 44 | Trial completion date: Dec 2021 --> May 2021 | Trial primary completion date: Oct 2021 --> May 2021 Phase classification: P2 --> P3 | N=228 --> 301 | Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
- | disitamab vedotin (RC48) / Rongchang Pharma
Journal: Conjugating MMAE to a novel anti-HER2 antibody for selective targeted delivery. (Pubmed Central) - Jul 2, 2021
Phase classification: P2 --> P3 | N=228 --> 301 | Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022 In vitro and in vivo experiments confirmed the targeted transport and release of RC48-ADC; it could selectively deliver MMAE to the targeted HER2-positive cell or tumour tissue, which could reduce off-target toxicity and enhance anti-tumour potency in humans.
- || telitacicept (RC18) / Rongchang Pharma
PK/PD data, Journal: Pharmacokinetics Analysis Based on Target-Mediated Drug Distribution for RC18, a novel BLyS/APRIL fusion protein to treat Systemic Lupus Erythematosus and Rheumatoid Arthritis. (Pubmed Central) - Jun 22, 2021
This mechanistic TMDD model integrated the interaction of RC18 with its target BLyS and accurately predicts both RC18 and RC18-BLyS complex profiles in RA and SLE patients. Simulated target change profiles can be used to help guide rational dose regimen selection and used as a biomarker for efficacy evaluation.
- |||| Tai'ai (telitacicept) / Rongchang Pharma
Enrollment closed: A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders (clinicaltrials.gov) - Jun 16, 2021
P3, N=118, Active, not recruiting, Sponsor: RemeGen Co., Ltd.
Simulated target change profiles can be used to help guide rational dose regimen selection and used as a biomarker for efficacy evaluation. Recruiting --> Active, not recruiting
- || RC118 / Rongchang Pharma
New P1 trial, Metastases: A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours (clinicaltrials.gov) - Jun 3, 2021
P1, N=33, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- || Tai'ai (telitacicept) / Rongchang Pharma
New P2 trial: A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy (clinicaltrials.gov) - May 26, 2021
P2, N=30, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- || Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy, Metastases: KEYNOTE-D78: A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 (clinicaltrials.gov) - May 26, 2021
P2, N=59, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
Recruiting --> Active, not recruiting Trial completion date: May 2023 --> Oct 2022 | Initiation date: May 2021 --> Sep 2021 | Trial primary completion date: Jan 2023 --> Jan 2022
- | telitacicept (RC18) / Rongchang Pharma
Preclinical, Journal: In vitro digestibility and structural control of rice starch-unsaturated fatty acid complexes by high-pressure homogenization. (Pubmed Central) - May 21, 2021
t12 was too mobile to form single helix, leading to the formation of loose matrix; t18 fitted better within the cavity of starch than c18, and formed structural domain with higher compactness and thermal stability; Rloa had lower complex index but higher degree of short-range order, and tended to form alternating amorphous and crystalline structure. The digestibility was higher in the order of Rloa, Rt18, Rc18 and Rt12.
- |||| Aidixi (disitamab vedotin) / Pfizer
New P2 trial, Combination therapy, Metastases: KEYNOTE-D78: A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 (clinicaltrials.gov) - May 9, 2021
P2, N=59, Not yet recruiting, Sponsor: RemeGen
- Herceptin (trastuzumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Matched therapies for advanced gastric cancer based on genotype: A real-world study in China. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4260;
Overall, 30 patients with advanced GC were treated with matched therapies according to specific genotype . These real-world outcomes suggested that matched therapies for advanced GC has promising efficacy, supporting the adoption of genotyping in treatment determination.
- disitamab vedotin (RC48) / Rongchang Pharma
[VIRTUAL] An open-label, single-arm, multicenter, phase II study of RC48-ADC to evaluate the efficacy and safety of subjects with HER2 overexpressing locally advanced or metastatic urothelial cancer (RC48-C009). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2096;
P2
These real-world outcomes suggested that matched therapies for advanced GC has promising efficacy, supporting the adoption of genotyping in treatment determination. In patients with HER2 overexpressing (IHC 2+ or 3+) mUC who had failed platinum, gemcitabine and taxane, and the great majority of whom had received ≥2 prior lines treatment, RC48-ADC has demonstrated consistently excellent efficacy and benefit-risk profile compared with the RC48-C005 study which enrolled patients with mUC who had received ≥1 line prior chemotherapy.
- Tuoyi (toripalimab) / Shanghai Junshi Biosci, Coherus
[VIRTUAL] RC48-ADC combined with toripalimab, an anti-PD-1 monoclonal antibody (Ab), in patients with locally advanced or metastatic urothelial carcinoma (UC): Preliminary results of a phase Ib/II study. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2046;
P1/2
RC48-ADC in combination with toripalimab had a good tolerance and promising anti-tumor activity in pts with mUC . Further evaluation of safety and efficacy is ongoing.
- disitamab vedotin (RC48) / Rongchang Pharma
[VIRTUAL] RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic breast cancer: A pooled analysis of two studies. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1316;
P1, P1/2
The 2.0 mg/kg Q2W showed a more favorable benefit-risk ratio than other dose levels . No new safety signals were observed .
- ||||| Tai'ai (telitacicept) / Rongchang Pharma
Enrollment closed: Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) (clinicaltrials.gov) - Apr 28, 2021
P3, N=335, Active, not recruiting, Sponsor: RemeGen
No new safety signals were observed . Recruiting --> Active, not recruiting
- ||| Tai'ai (telitacicept) / Rongchang Pharma
Enrollment closed, Enrollment change: A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sj (clinicaltrials.gov) - Apr 28, 2021
P2, N=42, Active, not recruiting, Sponsor: RemeGen
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=30 --> 42
- | Tai'ai (telitacicept) / Rongchang Pharma
Enrollment closed: A Study of RC18 Administered Subcutaneously to Subjects With Primary IgA(Immunoglobulin A) Nephropathy (clinicaltrials.gov) - Apr 28, 2021
P2, N=30, Active, not recruiting, Sponsor: RemeGen
Recruiting --> Active, not recruiting | N=30 --> 42 Recruiting --> Active, not recruiting
- || RC28-E / Rongchang Pharma
Trial completion: Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Apr 27, 2021
P1, N=12, Completed, Sponsor: RemeGen
Recruiting --> Active, not recruiting Recruiting --> Completed
- || RC98 / Rongchang Pharma
Enrollment open, Trial completion date, Trial primary completion date, Metastases: A Study of RC98 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Apr 27, 2021
P1, N=25, Recruiting, Sponsor: RemeGen
Recruiting --> Completed Not yet recruiting --> Recruiting | Trial completion date: Apr 2021 --> Nov 2021 | Trial primary completion date: Feb 2021 --> Aug 2021
- | RC28-E / Rongchang Pharma
Enrollment closed: Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration (clinicaltrials.gov) - Apr 27, 2021
P1/2, N=37, Active, not recruiting, Sponsor: RemeGen
Not yet recruiting --> Recruiting | Trial completion date: Apr 2021 --> Nov 2021 | Trial primary completion date: Feb 2021 --> Aug 2021 Recruiting --> Active, not recruiting
- || Tai'ai (telitacicept) / Rongchang Pharma
Enrollment open, Trial initiation date: RC18 in Patients With Relapsing Remitting Multiple Sclerosis?a Phase II Trial (clinicaltrials.gov) - Apr 27, 2021
P2, N=18, Recruiting, Sponsor: RemeGen
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Initiation date: Mar 2021 --> Jun 2021
- ||| RC28-E / Rongchang Pharma
Enrollment open: Evaluation of RC28-E Injection in Diabetic Macular Edema (clinicaltrials.gov) - Apr 27, 2021
P2, N=150, Recruiting, Sponsor: RemeGen
Not yet recruiting --> Recruiting | Initiation date: Mar 2021 --> Jun 2021 Not yet recruiting --> Recruiting
- ||| RC28-E / Rongchang Pharma
Enrollment open: Evaluation of RC28-E Injection in Diabetic Retinopathy (clinicaltrials.gov) - Apr 27, 2021
P2, N=120, Recruiting, Sponsor: RemeGen
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||| Aidixi (disitamab vedotin) / Pfizer
Enrollment open, Metastases: A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression (clinicaltrials.gov) - Apr 27, 2021
P3, N=351, Recruiting, Sponsor: RemeGen
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial primary completion date: A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects with Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis. (clinicaltrials.gov) - Apr 26, 2021
P3, N=480, Recruiting, Sponsor: RemeGen
Not yet recruiting --> Recruiting Trial completion date: Dec 2020 --> Mar 2023 | Trial primary completion date: Dec 2020 --> Dec 2022
- | Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial primary completion date: A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sj (clinicaltrials.gov) - Apr 26, 2021
P2, N=30, Recruiting, Sponsor: RemeGen
Trial completion date: Dec 2020 --> Mar 2023 | Trial primary completion date: Dec 2020 --> Dec 2022 Trial completion date: Dec 2020 --> Oct 2021 | Trial primary completion date: Oct 2020 --> Jul 2021
- ||| Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial primary completion date: A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders (clinicaltrials.gov) - Apr 26, 2021
P3, N=118, Recruiting, Sponsor: RemeGen
Trial completion date: Dec 2020 --> Oct 2021 | Trial primary completion date: Oct 2020 --> Jul 2021 Trial completion date: Jun 2021 --> Oct 2022 | Trial primary completion date: Dec 2020 --> Oct 2022
- | RC28-E / Rongchang Pharma
Trial completion date, Trial primary completion date: Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration (clinicaltrials.gov) - Apr 23, 2021
P1/2, N=36, Recruiting, Sponsor: RemeGen
Trial completion date: Jun 2021 --> Oct 2022 | Trial primary completion date: Dec 2020 --> Oct 2022 Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Oct 2020 --> Oct 2021
- || telitacicept (RC18) / Rongchang Pharma
Clinical, Journal: Telitacicept Following Plasma Exchange in the Treatment of Subjects With Recurrent NMOSD: Study Protocol for a Single-Center, Single-Arm, Open-Label Study. (Pubmed Central) - Apr 22, 2021
This study will explore the safety and effectiveness of telitacicept following plasma exchange regarding the time to recurrence in neuromyelitis optica spectrum disorder (NMOSD) for the first time. Clinical Trial Registration: Chictr.org.cn, identifier ChiCTR1800019427.
- || RC108 / Rongchang Pharma
Enrollment open, Metastases: A Study of RC108-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Apr 20, 2021
P1, N=32, Recruiting, Sponsor: RemeGen
Clinical Trial Registration: Chictr.org.cn, identifier ChiCTR1800019427. Not yet recruiting --> Recruiting
- ALPN-303 / Alpine Immune Sci
[VIRTUAL] ALPN-303, AN ENHANCED, POTENT DUAL BAFF/APRIL ANTAGONIST ENGINEERED BY DIRECTED EVOLUTION FOR THE TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) AND OTHER B CELL-RELATED AUTOIMMUNE DISEASES (Room 5) - Apr 6, 2021 - Abstract #EULAR2021EULAR_1277;
This novel Fc fusion molecule demonstrates favorable preliminary developability characteristics, including higher serum exposures and more potent immunosuppressive activities, which may enable lower clinical doses and/or longer dosing intervals than WT TACI-Fc therapeutics. ALPN-303 may thus be an attractive development candidate for the treatment of multiple autoimmune and inflammatory diseases, particularly B cell-related diseases such as SLE, SjS, and other connective tissue diseases.
- || Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Trial completion date, Trial primary completion date, Metastases: A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases (clinicaltrials.gov) - Mar 8, 2021
P2, N=228, Recruiting, Sponsor: RemeGen
ALPN-303 may thus be an attractive development candidate for the treatment of multiple autoimmune and inflammatory diseases, particularly B cell-related diseases such as SLE, SjS, and other connective tissue diseases. Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Jul 2020 --> Dec 2021
- |||||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Enrollment open, Trial completion date, Metastases: RC48-C012: A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 (clinicaltrials.gov) - Mar 7, 2021
P3, N=366, Recruiting, Sponsor: RemeGen
Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Jul 2020 --> Dec 2021 Not yet recruiting --> Recruiting | Trial completion date: Jun 2023 --> Dec 2023
- |||| RC28-E / Rongchang Pharma
New P2 trial: Evaluation of RC28-E Injection in Diabetic Macular Edema (clinicaltrials.gov) - Mar 3, 2021
P2, N=150, Not yet recruiting, Sponsor: RemeGen
- |||| RC28-E / Rongchang Pharma
New P2 trial: Evaluation of RC28-E Injection in Diabetic Retinopathy (clinicaltrials.gov) - Mar 3, 2021
P2, N=120, Not yet recruiting, Sponsor: RemeGen
- | Soliris (eculizumab) / Alexion Pharma, Ultomiris IV (ravulizumab IV) / Alexion Pharma
Journal: Emerging drugs for the treatment of neuromyelitis optica. (Pubmed Central) - Feb 4, 2021
For the first time in this disease, class I treatment evidence is available, but long-term data will be necessary to confirm the overall promising study results of the compounds close to approval. While drug development still centers around AQP4 antibody seropositive patients, current and future research requires consideration of possible diverging treatment demands for the smaller group of seronegative patients and patients with presence of MOG antibodies.
- | Tai'ai (telitacicept) / Rongchang Pharma
Trial initiation date: RC18 in Patients With Relapsing Remitting Multiple Sclerosis?a Phase II Trial (clinicaltrials.gov) - Feb 2, 2021
P2, N=18, Not yet recruiting, Sponsor: RemeGen
While drug development still centers around AQP4 antibody seropositive patients, current and future research requires consideration of possible diverging treatment demands for the smaller group of seronegative patients and patients with presence of MOG antibodies. Initiation date: Dec 2020 --> Mar 2021
- |||||||||| Aidixi (disitamab vedotin) / Pfizer
New P3 trial, Metastases: A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression (clinicaltrials.gov) - Jan 18, 2021
P3, N=351, Not yet recruiting, Sponsor: RemeGen
- | disitamab vedotin (RC48) / Rongchang Pharma
note to self: RC48-ADC now is Disitamab-Vedotin (Twitter) - Dec 19, 2020
- || Aidixi (disitamab vedotin) / Pfizer
Enrollment closed, Trial primary completion date, Metastases: RC48-C009: A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov) - Dec 17, 2020
P2, N=60, Active, not recruiting, Sponsor: RemeGen
Initiation date: Dec 2020 --> Mar 2021 Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2021 --> Dec 2020
- |||| disitamab vedotin (RC48) / Rongchang Pharma
Clinical: RC48-ADC, HER2-Targeting Antibody Drug Conjugate, demonstrates promising responses-51.2% of 43 patients-phase II trial from China in HER2+ (2-3+ IHC) advanced #UrothelialCarcinoma following chemo-further study warranted-comment-@BradMcG04 https://t.co/5bZprPUXRP @practiceupdate (Twitter) - Dec 2, 2020
- || Tai'ai (telitacicept) / Rongchang Pharma
New P2 trial: RC18 in Patients With Relapsing Remitting Multiple Sclerosis?a Phase II Trial (clinicaltrials.gov) - Nov 11, 2020
P2, N=18, Not yet recruiting, Sponsor: RemeGen
- || RC108 / Rongchang Pharma
New P1 trial, Metastases: A Study of RC108-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Nov 4, 2020
P1, N=32, Not yet recruiting, Sponsor: RemeGen
- | telitacicept (RC18) / Rongchang
I’m short RC18 (Twitter) - Oct 27, 2020
- || Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial primary completion date, Metastases: C003 CANCER: A Study of RC48-ADC in Subjects With Advanced Breast Cancer (clinicaltrials.gov) - Oct 12, 2020
P1/2, N=90, Recruiting, Sponsor: RemeGen
Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2021 --> Dec 2020 Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Aug 2020 --> Aug 2021
- | bleomycin / Generic mfg., BMS
Journal: Pharmacology Study of the Multiple Angiogenesis Inhibitor RC28-E on Anti-Fibrosis in a Chemically Induced Lung Injury Model. (Pubmed Central) - Sep 24, 2020
P1
RC28-E exhibits significant anti-fibrosis effects on Idiopathic pulmonary fibrosis (IPF) in vivo. Moreover, TGF-β induced fibroblast activation in vitro via the inhibition of the TGF-β downstream Smad pathway, thus providing potential therapeutics for clinical disease-related fibrosis-like IPF as well as chemotherapy-induced fibrosis in cancer therapy.